Events

Retiro De Equipo (Recall) de Alaris GP Large Volumetric Pump (general purpose infusion pump)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por CareFusion Australia 316 Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2012-RN-01162-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-11-22
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01162-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Carefusion, through its post market surveillance system, learned that the alaris gp infusion system produces very small air bubbles (less than 50ul) which are too small to trigger the lower configurable air-in-line detection thresholds (alarm) of the alaris gp infusion system - being 50-500ul, as configured by the user or 1ml over a rolling 15 min. window, which is considered state of the art and in compliance with en60601-2-24: particular requirements for the safety of infusion pumps and controllers (according to swissmedic).
  • Acción
    CareFusion is providing additional information and warnings in relation to at-risk groups of patients such as those with artial septal defect, neonates and those using multiple lines.

Device

Alaris GP Large Volumetric Pump (general purpose infusion pump)
  • Modelo / Serial
    Alaris GP Large Volumetric Pump (general purpose infusion pump)Product Ref: 80063UN01, 80263UN01, 80263UN01-G, 9002MED01, 9002MED01-GAll serial numbersARTG number: 130389
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd